# K083508: Swabcap

- Pathway: 510(k) (Traditional)
- Applicant: Excelsior Medical Corp.
- Decided: Apr 28, 2009 after 153 days
- Product code: QBP (Cap, Device Disinfectant)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K030467 (2003). 5 ancestors in all.
23 later devices descend from it; 6 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080579: Effectiv (TM) Cap, Hospira, Inc. (2008) Summary page 5.
- K080466: Alcohol Pad, 122 Corporation (2008) Summary page 5.
- (no number) Alcohol Prep Pad, Professional Disposables Inc.: named in the summary without a submission number

## Most influential descendants
- K093229: Catheter Connections Dualcap (2010), 8 descendants of its own
- K111992: Curos Port Protector (2012), 6 descendants of its own
- K112791: Sitescrub Ipa Device (2012), 3 descendants of its own
- K130975: Swabcap and Swabflush (2013), 2 descendants of its own
- K113842: Catheter Connections' Dualcap Solo (2012), 2 descendants of its own

## Indications for use
SwabCap™ is intended for use on swab-able luer access valves as a disinfecting cleaner prior to line access and to act as a physical barrier to contamination between line accesses. SwabCap™ will disinfect the valve five (5) minutes after application and act as a physical barrier to contamination for up to ninety-six (96) hours under normal conditions if not removed.

Source page: https://510kreport.com/device/K083508
Methodology: https://510kreport.com/methodology